Home-HF: Evaluation of Patients With Heart Failure Using Home Telemonitoring

This study has been completed.
Sponsor:
Collaborator:
Honeywell HomMed
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00312884
First received: April 7, 2006
Last updated: April 26, 2016
Last verified: November 2007
  Purpose

This project, using home monitoring for the signs and symptoms of heart failure, aims to empower patients to be actively involved in their care and provide rapid access to healthcare services and advice when needed. The telemonitoring system is easy to use and ensures the accurate transfer of information from the home to the hospital. The information is then screened and if important changes are seen, the patient will be contacted by a heart failure nurse who will offer advice and may arrange a clinic visit or suggest alterations to the medication. The project uses modern technology to provide disease management, links the patient in their home with the hospital and reinforces education and self-care behaviour. This innovative programme will be tested to see if it reduces the risk of re-admission to hospital, reduces anxiety, improves quality of life following a hospital admission for heart failure and whether this represents good value for money in terms of the health benefits it provides.

Hypothesis:

Patients using home telemonitoring of signs and symptoms of heart failure following discharge from hospital with chronic heart failure have a reduced risk of all-cause re-hospitalisation when compared with usual care.


Condition Intervention Phase
Heart Failure
Device: HomMed Telemonitoring System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Home-HF: a Randomised Controlled Evaluation of Home Telemonitoring of Patients With Heart Failure Recently Discharged From Hospital.

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Days Alive and Outside of Hospital [ Time Frame: From date of randomisation for 180 days ] [ Designated as safety issue: Yes ]
    Days alive and outside of hospital (i.e. not admitted)

  • Patients Hospitalised (All Cause) [ Time Frame: From randomisation date to 180 days ] [ Designated as safety issue: No ]
  • Number of Days Spent in Hospital [ Time Frame: From randomisation date for 180 days ] [ Designated as safety issue: No ]
  • Number of Hospitalisations (All Cause) [ Time Frame: from randomisation for 180 days ] [ Designated as safety issue: No ]

Enrollment: 182
Study Start Date: May 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual Care
Recieved usual hospital and community care
Device: HomMed Telemonitoring System
The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
Experimental: Intervention Arm
Recieved telemonitoring
Device: HomMed Telemonitoring System
The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home

Detailed Description:

This project, using home monitoring for the signs and symptoms of heart failure, aims to empower patients to be actively involved in their care and provide rapid access to healthcare services and advice when needed. This innovative programme will be tested to see if it reduces the risk of re−admission to hospital. In addition economic evaluation will assess whether this represents good value for money in terms of the health benefits it provides.

After fulfilling the inclusion criteria and being consented into the study, the patients will be randomised into either the control or intervention group in a 1:1 ratio.

Intervention Group:

Prior to hospital discharge the patient and carer/family will be shown how to use the HomMed Telemonitoring equipment. Within two working days of discharge the equipment will be installed in their home by the study nurse who will remind them of its use. They will be provided with a written management plan and advice regarding self−monitoring.They will be asked to monitor signs and symptoms of their disease daily using the HomMed telemonitoring system connected to their home phone line.

The data will be reviewed every working day by a study nurse and examined for variance from the agreed parameters. If clinically significant changes are noted a standard protocol will be used to guide the management.

Control group:

Within two working days of discharge the study nurse will visit patients in the control group and provide them with a written management plan and advice regarding self−monitoring. They will receive usual care for that centre which will consist of a recommendation to visit their GP on hospital discharge and a subsequent review in the outpatient clinic. Informal support offered through the hospital heart failure nurse will continue and this contact will be recorded.

Within both groups the Hospital Anxiety and Depression (HAD) questionnaire, the Minnesota Living with Heart Failure(MLWHF) tool and the Euroqol (EQ−5D) questionnaire will be completed at randomisation, and again at 3 and 6 months following hospital discharge. They will be asked to return completed questionnaires in a pre−paid envelope.

Data on patients' use of healthcare services will be collected from both groups using a combination of retrospective questionnaires and prospective health diaries, which will be returned at 3 and 6 months after randomisation.

Drug optimisation will be assessed through review of medication prescription, and drug utilisation through patient self−report.These data will also be collected at 3 and 6 months.

Patients within both groups will be involved in the study for a period of 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • NYHA class II - IV (i.e. breathlessness at rest or on mild-moderate exercise) at time of randomisation (hospital discharge)
  • Proven diagnosis of heart failure, in line with the guidelines for management of chronic heart failure of the European Society of Cardiology or as determined by the cardiologist or physician caring for the patient
  • Admission to hospital following a new diagnosis of heart failure or episode of acute decompensation of chronic heart failure
  • Home telephone line
  • Deemed fit for discharge home by the clinical team

Exclusion Criteria:

  • Dementia/confusion which is likely to interfere with the use of the HomMed telemonitoring equipment.
  • < 18 years of age
  • Lack of home telephone line
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312884

Locations
United Kingdom
West Middlesex University Hospital
Greater London, Middlesex, United Kingdom, TW7 6AF
Ealing Hospital
London, United Kingdom, UB1 3HW
Hillingdon Hospital
Uxbridge, United Kingdom, UB8 3NN
Sponsors and Collaborators
Imperial College London
Honeywell HomMed
Investigators
Principal Investigator: Martin R Cowie, MD MSc FRCP Imperial College London & Royal Brompton and Harefield Hospital NHS Trust
  More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00312884     History of Changes
Other Study ID Numbers: 2006EP001B  05/Q0411/112 
Study First Received: April 7, 2006
Results First Received: October 27, 2015
Last Updated: April 26, 2016
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
telemonitoring
heart failure
randomised
hospitalisation
HomMed

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 25, 2016